Computer System Validation (CSV) Engineer

Dallas, IA - USA

Monthly Salary: Not Disclosed

Posted on: 30+ days ago

Vacancies: 1 Vacancy

Job Summary

Job Title: Computer System Validation (CSV) Engineer
Location: Dallas TX
Duration: Long-Term Contract

Summary:
Experienced CSV Engineer responsible for ensuring compliance data integrity and validation of computerized systems in regulated environments. The role focuses on maintaining GxP FDA and EMA compliance while supporting system qualification and lifecycle activities.

Key Responsibilities:

Develop and execute CSV deliverables per GAMP 5 and ALCOA principles.
Ensure compliance with data integrity change control and deviation management.
Author and execute Validation Plans Risk Assessments IQ/OQ/PQ and Summary Reports.
Collaborate with Quality IT and Engineering teams for system validation and audits.
Support lifecycle management and system upgrades.

Qualifications:

Bachelors degree in Engineering Computer Science or related field.
5 years of CSV experience in pharma biotech or medical device industries.
Strong knowledge of GAMP 5 21 CFR Part 11 Annex 11 and ALCOA.
Experience with systems like LIMS MES ERP and SCADA.
Excellent documentation and communication skills.

Job Title: Computer System Validation (CSV) Engineer Location: Dallas TX Duration: Long-Term Contract Summary: Experienced CSV Engineer responsible for ensuring compliance data integrity and validation of computerized systems in regulated environments. The role focuses on maintaining GxP FDA a...